REACH What is REACH? European Union regulation concerning R - - PowerPoint PPT Presentation

REACH

What is REACH?

• European Union regulation concerning Registration, Evaluation,

Authorisation and restriction of Chemicals

• Aims:

– To provide a high level of protection of human health and the environment from the use of chemicals – To make manufacturers and importers who place chemicals on the market responsible for understanding and managing the risks associated with their use – To allow the free movement of chemicals on the EU market – To enhance innovation in and the competitiveness of the EU chemicals industry – To promote the use of alternative methods for the assessment of the hazardous properties of substances and read across of data

REACH Requirements

• REACH applies to substances manufactured or imported into the EU

in quantities of 1 tonne per year or more

• REACH requires manufacturers and importers of substances to

register them with the European Chemicals Agency (ECHA)

• It is illegal to manufacture or supply substances that have not been

registered (unless substance exemptions apply)

REACH Requirements

• Registration takes place by means of a registration dossier which

must be provided to ECHA

• Manufacturers and importers must collect and collate specified sets
• f information on properties of substances they manufacture or

supply at or above 1 tonne per year

• REACH will ensure very high risk substances are adequately

controlled and progressively substituted by safer substances/technologies or only used where there is an overall benefit for society

General Registration Dossier

• General Registrant Information
• Substance Identification
• Substance Manufacture & Use
• Classification & Labelling
• Guidance on Safe Use Concerning
• Exposure Information
• Physiochemical Properties
• Toxicological Information
• Ecotoxicological Information
• Methods of Detection And Analysis

REACH Requirements

• Manufactures and importers must provide downstream users with

the risk information needed to use the substance safely

• This is done via classification and labelling and Safety Data Sheets

(SDS) where needed

Information required in SDS

1. Substance & Company Identification 2. Hazards Identification 3. Compositional Information 4. First Aid Measures 5. Fire Fighting Measures 6. Accidental Release Measures 7. Handling & Storage Information 8. Exposure Controls/Personal Protection 9. Physical & Chemical Properties 10. Stability & Reactivity 11. Toxicological Information 12. Ecological Information 13. Disposal Considerations 14. Transport Information 15. Regulatory Information 16. Other Information

REACH Requirements

• The following materials are exempted from REACH:

– Specific substances listed under Annex IV of Regulation (see: http://www.reach- compliance.eu/english/legislation/reach-exemptions.html) – Substances covered by Annex V (includes substances which occur in nature, if they are not chemically modified, including natural gas, LPG, crude oil) – Monomers bound into polymers (but registration required if monomer present at ≥ 2% w/w in the polymer and is at ≥ 1 tonne per annum) – Polymers – Food & food ingredients – Waste and certain recycled materials – Substances needed in the interests of defence

• Petroleum substances (except sulphur) are recognised by REACH as substances of

“Unknown or Variable composition, Complex reaction products or Biological materials” (“UVCBs”)

• Petroleum products and blendstocks imported in quantities in excess of 1 tonne per

annum are generally not exempted and will all need to be registered – Concawe have undertaken a programme of risk assessment of petroleum substances, including development of risk assessment methodologies to which members have access – see link at end of talk

REACH Implementation Timeline

DATE TARGET

01/06/07 REACH comes into force 01/06/08 ECHA becomes operational 01/06/08 to 30/11/08 Pre-registration period (during which substances already being manufactured and supplied (“Phase-in” substances) are “pre-registered” (without a full registration dossier) to give extended registration deadlines) 01/12/08 Registration for existing substances (that have not been pre-registered) begins 01/01/09 List of pre-registered substances published and Substance Information Exchange Forum (SIEF) formed 01/12/10 Phase 1 – Deadline for registration for pre-registered “phase-in” substances supplied at greater than or equal to 1000 tonnes per annum (also ≥ 100 tonnes/annum if classed under CHIP* as very toxic to aquatic organisms and ≥ 1 tonne/annum if classed under CHIP* as Cat 1 or Cat 2 carcinogens, mutagens or reproductive toxicants) 01/06/13 Phase 2 – Deadline for registration of substances supplied at greater than or equal to 100 tonnes per annum 01/06/18 Phase 3 – Deadline for registration of substances supplied at greater than or equal to 1 tonne per annum *CHIP = Chemical Hazard Information and Packaging for Supply regulations

MTD REACH Services

• Education

– Training on nature of different commodities, production processes, additives – Significance of chemical & physical testing

• Testing Services

– Full product survey – Compositional Testing for Registration Dossier – Physiochemical Testing

• Company Product Survey

– Identification of all products and other materials (e.g. Additives) shipped at quantities > 1 tonne per annum – Production of reference specifications – Guidelines for independent inspectors

• Safety Data Sheet Preparation

– Compositional data – Handling & Storage Information – Exposure Controls/Personal Protection – Physical & Chemical Properties

Useful Links

• European Chemicals Agency Website:

http://echa.europa.eu/

• EU REACH Document:

http://www.hse.gov.uk/REACH/resources/regulation.pdf

• Concawe:

http://www.concawe.be/Content/Default.asp (Oil Companies’ European Association for Environment, Health & Safety in Refining & Distribution)